1. Field of the Invention
The present invention relates to a composition and method of use for the treatment of mucocutaneous lesions by the topical administration of an effective amount of a composition comprising diphenhydramine, lidocaine, aloe, propolis and sufficient base to obtain a pH of 8-9.
2. Description of the Prior Art
Various agents have been used to treat oral lesions within the oral cavity. Among the most widely used are gentian violet, methylene blue, hydrogen peroxide and surfactants, such as ceepyrn (Cepacol). However, these agents have met with limited success and their clinical efficacy leaves much to be desired.
Antihistamines have been commonly employed in dental practice however, mostly for the allergic reactions involving the oral tissues and structures. Among the most widely used antihistamines are ChlorTrimeton, Benadryl, Pyribenzamine and Phenergan. The use of antihistamines has met with very limited success in controlling edema, facial swelling or trismus, etc. resulting from oral surgical procedures.
Corticosteroids have been used in dentistry but only to a limited extent. The most widely used corticosteroid for interoral use is Kenolog (triamcinolone acetonide) which is marketed in an adhesive base (Orabase). The use of this preparation is quite limited since its use is contraindicated in the presence of fungal, viral or bacterial infections of the mouth or throat.
Local anesthetics for topical use are available for dental practice. Tetracaine and dibucaine produce the most adequate topical anesthesia. However, the most widely used is Xylocaine Viscous (lidocaine) available as a 2% aqueous solution adjusted to a pH of 6.0-7.0. It is indicated for use of inflamed and denuded mucus membranes. Generally for an adult an amount of less than 1 ounce, usually 1/2 ounce, is administered at intervals of not less than 3 hours with no more than 8 doses being administered in a 24 hour period. The maximum single does for a healthy adult is 2 mg/lb body weight and does not in any case exceed a total of 300 mg. The peak effect on the mucus membrane appears in 2-5 minutes and the duration of the effect is 30-60 minutes.
When using oral topical anesthetics the patient is cautioned to avoid food and beverages for one hour after application since the production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration. Numbness of the tongue or buccal mucousal may increase the danger of biting trauma.
Diphenhydramine HCl elixer is used topically as a 10 mg per 4 ml elixir or may be diluted with equal parts of water for its minor anesthetic effect for painful oral conditions such as pemphigus vulgaris, stomatitis, aphthosis and glossodynia. Diphenhydramine is also used topically as a cream (Surfadil) or a lotion (Ziradryl).
Havsteen discusses flavonoids their presence in bee propolis and their therapeutic applications such as pain relief and promotion of healing. B. Havsteen, Flavanoids, A Class of Natural Products of High Pharmacology Potency, Biochemical Pharmacology, Volume 32, No. 7, pp. 1141-1148, 1983.
Product literature for a tooth gel "Forever Bright" indicates the use of aloe vera as a inhibitor and a killer of bacteria which are known to cause plaque and bee propolis as having a natural antibiotic action.
U.S. Pat. No. 3,892,853 teaches the use of aloe vera gel by physicians and dentists in relieving pain and in promoting healing of topical and other lesions.
Also in the prior art is a mixture used to treat oral lesions comprising equal amounts of Benadryl, Amphojel and Xylocaine 2% solution, hereinafter Original Composition. The therapeutic dose is one teaspoonful (5 ml) and at low doses this composition does not interfere with swallowing.
The treatment of oral lesions by oral compositions has heretofore met with limited success. With some compositions, the anesthetic effect is coupled with a caution against eating or drinking for about an hour after applying because of the potential aspiration of swallowed material. With other compositions the anesthetic effect either takes too long to reach a therapeutic level or fails to numb the area altogether. For example, the treatment of canker sores which are characterized by ulcers which are confined to the oral mucosa in an otherwise healthy patient, with oral compositions has met with limited success. Present remedies such as spirits of camphor, alcohol 70%, salt water rinses, Blistex, cortizone-like drugs and topical adhering gels such as Orabase have been recommended.
For recurrent or the more troublesome causes of oral lesions such as recurrent herpes simplex or recurrent aphtheloris stomatitis (canker sores) no satisfactory topical treatment is available. The efficacy and safety of neutral red dye and photo therapy (photo inactivation), topical ether or alcohol has not been established. Idoxuridin is of questionable benefit.
A more troublesome oral lesion is secondary to cancer chemotherapy, for example methotrexate therapy. These are large, deep necrotizing ulcers which may effect all mucosal surfaces. Mouth rinses which include a local anesthetic, such as Dyclone, and an antihistamine, such as diphenhydramine, have been used for these lesions.
Zovirox topical ointment is indicated for the treatment of herpes genitalis. Topical application has shown a decrease in healing time and in some cases a decrease in the duration of viral shedding and duration of pain.
What is needed is a composition which will provide relatively longlasting relief of the symptoms associated with oral cavity lesions and promote the healing of the lesions. The composition of the invention allows for the patient to maintain adequate nutritional intake, by relieving symptoms associated with oral lesions.
It is an object of the present invention to provide a mucocutaneous composition that will provide immediate and relatively long-lasting relief from adverse symptoms such as itching, burning and pain caused by mucocutaneous lesions.
It is a further object of the present invention to provide a mucocutaneous composition that will promote healing.
It is a further object of the present invention to provide a mucocutaneous composition which is easy to administer.
It is a further object of the present invention to provide an oral composition that will promote the well being of the patient by diminishing the pain and discomfort of the oral lesion thereby allowing the patient to ingest food and beverages.
It is a further object of the present invention to provide an oral composition which produces a selective topical anesthetic effect at the lesion site(s) when the composition of the invention is applied orally, thereby allowing the ingestion of food and beverages shortly after administration.
The foregoing has outlined some of the more pertinent objects of the invention. These objects should be construed to be merely illustrative of some of the more prominent features and applications of the intended invention. Many other beneficial results can be attained by applying the disclosed invention in a different manner or modifying the invention within the scope of the disclosure. Accordingly, other objects and a fuller understanding of the invention may be had by referring to the summary of the invention and the detailed description describing the preferred embodiment in addition to the scope of the invention defined by the claims.